A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH) (DASH)
29 mai 2026 mis à jour par: K Rivet Amico, University of Michigan
People using HIV self-testing (HIVST) need access to quality HIV-prevention programming, including education and exploration of pre-exposure prophylaxis (PrEP) - an effective biomedical prevention tool that continues to expand in choices and access points in the US.
HIVST and PrEP are both central to ending the HIV epidemic, but presently they are not linked together in a systematic way.
To address the critical need for PrEP programming to accompany HIV self-testing (HIVST), our study will work with experts and HIVST users to develop and pilot a novel, interactive, mobile friendly PrEP decisional-aid mobile optimized website that helps to raise awareness around PrEP and guides people through a PrEP-decision-making process that matches their needs and values, and links people to resources for local or online PrEP.
This PrEP Decisional Aid to accompany Self HIV-test kits (the DASH app) will be in a randomized controlled pilot trial with 120-170 HIV self-test kit users in the CDC's Together TakeMeHome HIV-test kit dissemination program.
PrEP uptake at 3-months (primary outcome) will be compared between arms descriptively and with logistic regression models.
Change in additional PrEP related factors (knowledge, stigma, decisional conflict, barriers and facilitators) will be assessed as secondary outcomes.
Implementation metrics, acceptability and feasibility will also be evaluated quantitatively and qualitatively.
Results will inform revisions and recommendations for a decisional aid for raising PrEP awareness and use among self HIV-test users.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
This mixed methods intervention development and implementation hybrid (type 1) study will pilot a self-administered PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH). Recruiting from Together TakeMeHome (TTMH) HIVST kit recipients, the proposed pilot has 3 specific aims. The first aim was to develop the PrEP decisional aid for dissemination with self-administered HIV test kits (DASH) through iterative expert and community consultation.
AIM 2- Pilot DASH with TTMH HIVST kit recipients and determine direction and magnitude of impact on PrEP awareness, intentions and starts. HIVST recipients from TTMH will be recruited into a 3-month pilot completing online surveys assessing PrEP awareness, knowledge, intentions, and use at baseline, and 1- and 3-month follow-up. Participants randomly assigned to the DASH arm, versus the measures-only arm, receive the DASH link post baseline. A minimum of 120 and maximum of 170 (to reach 60 intervention arm participants who complete 1 full session of the DASH app) will be enrolled. PrEP uptake at 3-months (primary outcome) will be compared between arms descriptively and with logistic regression models (both intent to treat and as-treated). Change in additional PrEP related factors (knowledge, stigma, decisional conflict, barriers and facilitators) will be assessed as secondary outcomes. Longitudinal growth modelling will be used to analyze over-time data between study arms. H2: DASH arm participants will have more self-reported PrEP starts (primary) by 3 months than those in the comparison condition. H3: DASH arm participants will report more favorable secondary outcomes on follow-up surveys.
AIM 3- Conduct mixed methods evaluation of acceptability, feasibility and experiences with the DASH. All participants will complete a brief survey on acceptability of the PrEP-related resources received (DASH or standard for what is locally available). Patterns of utilization of DASH components, including use of links to PrEP services, will be summarized. Qualitative virtual in-depth interviews with 30 participants (20 DASH, 10 control) will explore nuanced aspects of PrEP decision making and expand on the quantitative data. H4: DASH will be evaluated as acceptable and feasible.
Type d'étude
Interventionnel
Inscription (Estimé)
170
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Age 18-39
- Comfort with English material and communication (oral and written)
- Access to internet
- HIV negative (self-report)
- PrEP Naive (never used PrEP)
Exclusion Criteria:
• Ever used PrEP
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Comparison condition
Participants in the comparison condition do not receive additional PrEP related information through the project- but have access to PrEP information from the self-test kit and other programs that are available.
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Expérimental: DASH Intervention Arm
Participants receive access to the DASH app through an emailed link with reminders to use the link at least one during the 3 month study period
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Participants assigned to the intervention arm will be provided with a unique code to access the login for the DASH app.
The app provides a PrEP information, explores values and decisions around PrEP, and leads participants through an exploration of their PrEP decisions with links to PrEP resources (local and online) for those interested in findings out more about or starting PrEP.
Participants are asked to complete one complete session and return back to the app at any time during their participation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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PrEP Start
Délai: 3 months
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Self-reported PrEP initiation determined by a single item asking "Are you currently using PrEP?" [Yes/No]
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3 months
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Theoretical Framework of Acceptability Scale for DASH
Délai: Month 1 and month 3
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Adapted from the Theoretical Framework of Acceptability Scale.
9 items assess affective attitudes, burden, perceived effectiveness, intervention coherence, opportunity costs, self-efficacy and ethicality- with likert scale of 1 to 5. A total acceptability score can be calculated by summing responses to items producing a range of 9 to 45 with higher scores reflecting higher overall acceptability.
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Month 1 and month 3
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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PrEP Information
Délai: Baseline, Month 1 and Month 3
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Accurate information about PrEP is assessed using using 10 items stated- 5 states as self-ratings of information (I know...) and 5 as facts with answer options of True, False, Not sure/don't know.
Scores are summed across all items with a range of 0 (no perceived knowledge and none correct) to 10 (true to all perceived knowledge questions and correct on all factual items).
Higher scores reflect higher knowledge/information accuracy about PrEP.
Outcomes use baseline to determine gains in knowledge over time.
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Baseline, Month 1 and Month 3
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Movement on PrEP Care Continuum
Délai: Baseline, Month 1 and Month 3
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Movement through the PrEP continuum of care is calculated at month 1 and month 3. Participants are characterized as not interested in PrEP, interested in PrEP, spoke with a navigator about PrEP since starting the DASH project, spoke with a provider about PrEP since starting the DASH project, or started PrEP.
Movement is identified by determing if the participant has made forward movement in this process or has maintained being on PrEP between month 1 and month 3 surveys.
Stage is ordinal and descriptive.
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Baseline, Month 1 and Month 3
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Decisional Conflict
Délai: Baseline, Month 1 and Month 3
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The Decisional Conflict Scale adapted for PrEP related decisions is a 16 item measure providing states and likert scale response (5 points ranging from strongly disagree=4 to strongly agree=0).
Subscales include informed decisions (3 items), values clarity (3 items), support (3 items), uncertainty (3 items) and effective decision (4 items).
Each subscale is created by summing the responses items, dividing by the total number of items in the scale, and multiplying by 25.
Scores range from 0 (good decision) to 100 (bad decision).
A total score is created by summing all 16 items, dividing by 16, and multiplying by 25 with a range of 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Total score will be used for the outcome.
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Baseline, Month 1 and Month 3
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PrEP Motivation
Délai: Baseline, Month 1 and Month 3
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PrEP motivation is measured with 17 items created for the study that assesses attitudes and beliefs, distrust, and facilitators of PrEP use framed as statements with a 5 point likert scale (strongly disagree=1 to strongly agree=5).
All items are summed and divided by 17 to create a total motivation scale score (average response, range of 1 to 5).
Higher scores reflect higher motivation to use PrEP.
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Baseline, Month 1 and Month 3
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DASH Trustworthiness
Délai: Month 1
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Adapted Trust and Suspicion IT Scale, 6 items adapted to reflect DASH from the measure's trustworthiness scale assess trust in the information provided by the DASH app (statements with 7-point likert response options of Strongly disagree to strongly agree).
Items are totaled and divided by 6 to create an average trust in DASH score (range of 1 to 7) with higher scores reflecting higher levels of trust.
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Month 1
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System Usability Scale
Délai: Month 1
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10 items (statements) from the System Usability Scale adapted to reflect experiences, thoughts, and beliefs around DASH with 5-point likert scale response options (0=strongly disagree to 4= strongly agree) assess overall "usability" of the DASH app.
After reverse scoring items reflecting burden/low usability, item responses are summed and multiplied by 2.5 producing a range of 0 to 100 with higher scores reflecting higher usability.
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Month 1
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Perceived Usefulness of DASH
Délai: Month 1
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Perceived Usefulness created for this study advised by previous evaluations of decisional aid tools.
9 items assessing general and specific characteristics of the app that were "helpful", "useful".
and "facilitative" for PrEP related awareness and decision making.
A 5-point likert scale (strongly disagree=1 to strongly agree) is used with total score (divided by 9) providing an average agreement (range of 1 to 5) with usefulness.
Higher scores reflect higher levels of perceived usefulness of the DASH app.
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Month 1
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Suspiciousness of DASH
Délai: Month 1
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Suspicion of DASH is assessed with 4 items from the Trustworthiness and IT Suspicion scale's suspicion subscale (statements with 7-point likert response options of Strongly disagree to strongly agree).
After reverse scoring relevant items, scores are summed and divided by 4 to create an average (range of 1 to 7) with higher scores reflecting higher levels DASH suspicion.
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Month 1
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: K Rivet Amico, PhD, University of Michigan
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 avril 2026
Achèvement primaire (Estimé)
31 octobre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
8 mai 2026
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HUM00284303
- 5R34MH135799 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
National Data Archive received participant data using a psuedo identification number
Délai de partage IPD
NDA data is uploaded quarterly and is available to public for use after the completion of the trial
Critères d'accès au partage IPD
NDA has a system that researchers can use to request data access
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .